FDA Adverse Event
Malfunction
Summary report: N
K-WIRE BENDING PLIERS
MDR report key: 1693452
·
Received May 7, 2010
Report
- Report Number
- 8010177-2010-00209
- Event Type
- Malfunction
- Date Received
- May 7, 2010
- Date of Event
- April 16, 2010
- Report Date
- April 16, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- EJY
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE ANALYSIS IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PART OF THE INSTRUMENT THAT ALLOWS IT TO BEND AND CUT THE WIRE BROKE OFF SO IT CAN NO LONGER FUNCTION CORRECTLY. FOUND BEFORE THE SURGERY SO NEVER ENTERED INTO SURGERY".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-WIRE BENDING PLIERS | INSTRUMENT | EJY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | U8-08/04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |